Nemvaleukin alfa (Nemvaleukin) has been granted fast-track designation by the FDA for the treatment of patients with mucosal melanoma who have received prior treatment with an anti–PD-L1 therapy, according to a press release from Alkermes.1
Archive | Regulatory
FDA Grants Fast Track Designation to Nemvaleukin Alfa for Mucosal Melanoma
Posted in Melanoma News, Regulatory, Publications
FDA Sets PDUFA Date for Pembrolizumab
Merck announced that its phase 3 KEYNOTE-716 (NCT03553836) trial investigating pembrolizumab (Keytruda) has met its primary endpoint…
Posted in Melanoma News, Regulatory, Publications
FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma
The FDA has granted an orphan drug designation to alrizomadlin (APG-115) as a potential therapeutic option for patients with stage IIB-IV melanoma, according to an announcement from Ascentage Pharma, the drug developer.1
Posted in Melanoma News, Regulatory, Publications
FDA Grants Orphan Drug Designation to Cavrotolimod for Merkel Cell Carcinoma
The FDA has granted an orphan drug designation to cavrotolimod (AST-008) for the treatment of patients with Merkel cell carcinoma (MCC), according to an announcement from Exicure, Inc.1
Posted in Melanoma News, Regulatory, Publications
